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Evaluation of Long-term Neurodevelopment in Neonatal Encephalopathy by Infant Treadmill

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ClinicalTrials.gov Identifier: NCT03527498
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : March 9, 2022
Sponsor:
Collaborator:
Shanghai 6F+ Early intervention center for high risk preterm infants
Information provided by (Responsible Party):
Children's Hospital of Fudan University

Study Description
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Brief Summary:
There is no international application of infant running stimulation system to evaluate the brain injury in children with various stages of nerve and motor development in a large sample of studies. The study of neonatal brain injury is only limited to intraventricular hemorrhage(IVH),periventricular leukomalacia(PVL), Down's syndrome(DS), premature birth of these four conditions, and the number of samples in the single digits, there is no representative of the disease population. Therefore, from the newborn to the infant development of the critical period, the investigator will refer to the previous treadmill parameters set on the research results, optimize the application of neonatal treadmill. The study hypothesized that neonatal treadmill stimulation with brain-injured children could improve his / her staggered gait characteristics and long-term nerve development through large sample data. It is important to preserve and analyze the gait characteristics and the changes of nerve development in every stage of growth and development of neonates with brain injury so as to provide clinical evidence for rehabilitation intervention. It is of great significance to judge whether this technique can be used in the early stage of brain injury in neonates.

Condition or disease Intervention/treatment Phase
Hypoxic-Ischemic Encephalopathy Periventricular Leukomalacia Intraventricular Hemorrhage Bilirubin Encephalopathy Kernicterus Hypoglycemia, Neonatal Cerebral Infarction Device: Baby treadmill Behavioral: Physical rehabilitation training Not Applicable

Detailed Description:
There is no international application of infant running stimulation system to evaluate the brain injury in children with various stages of nerve and motor development in a large sample of studies. The study of neonatal brain injury is only limited to intraventricular hemorrhage(IVH),periventricular leukomalacia(PVL), Down's syndrome(DS), premature birth of these four conditions, and the number of samples in the single digits, there is no representative of the disease population. Therefore, from the newborn to the infant development of the critical period, the investigators will refer to the previous treadmill parameters set on the research results, optimize the application of neonatal treadmill. The study hypothesized that neonatal treadmill stimulation with brain-injured children could improve his / her staggered gait characteristics and long-term nerve development through large sample data. It is important to preserve and analyze the gait characteristics and the changes of nerve development in every stage of growth and development of neonates with brain injury so as to provide clinical evidence for rehabilitation intervention. It is of great significance to judge whether this technique can be used in the early stage of brain injury in neonates.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All subjects were divided into two groups: intervention group A (treadmill intervention + routine physical rehabilitation therapy) and positive control group (receiving routine physical rehabilitation therapy only).
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Clinical Trial of Infant Treadmill for Long-term Neurodevelopmental Evaluation of Neonatal Encephalopathy
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: intervention group
Baby treadmill + physical rehabilitation training
 Device: Baby treadmill
The newborns who received treadmill intervention were stimulated by running 3 times a week for a total of 10 minutes each time (complete in 5 cycles, 2 minutes per cycle, 2 minutes after the completion of one cycle and rest for 2 minutes to start the next cycle). Until the completion and completion of the five cycles). During the remaining four days of each week, other physical rehabilitation training is carried out by the rehabilitator in accordance with the established rehabilitation plan. The stimulation of running lasted from 3 months of corrected gestational age to being able to walk alone for 3 steps or to correct for 18 months.

Behavioral: Physical rehabilitation training
Suitable for general physical rehabilitation training of all infants with cerebral palsy.
Active Comparator: positive control group
Physical rehabilitation training only
 Behavioral: Physical rehabilitation training
Suitable for general physical rehabilitation training of all infants with cerebral palsy.


Outcome Measures
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Primary Outcome Measures :
  1. score from Bayley Scales of Infant and Toddler Development testing [ Time Frame: The length of time from birth to the corrected age of 18 months ]
    These scores are largely used for screening, helping to identify the need for further observation and intervention, as infants who score very low are at risk for future developmental problems.

  2. fractional anisotropy(FA) [ Time Frame: The length of time from birth to the corrected age of 18 months ]
    a variable from Diffusion Tensor Image（DTI）sequence of MRI

  3. the value of Amplitude of Low Frequency Fluctuation(ALFF) [ Time Frame: The length of time from birth to the corrected age of 18 months ]
    a variable from resting-blood oxygenation level dependent（BOLD）sequence of MRI


Secondary Outcome Measures :
  1. Alberta Infant Motor Development Assessment [ Time Frame: The length of time from birth to the corrected age of 18 months ]
    Neurodevelopmental evaluation scale

  2. Peabody motor development scale [ Time Frame: The length of time from birth to the corrected age of 18 months ]
    The Peabody Developmental Motor Scales (PDMS) is composed of six subtests that measure interrelated abilities in early motor development. It was designed to assess gross and fine motor skills in children from birth through five years of age. Reflexes (Re), Stationary (St), Locomotion (Lo) , Object Manipulation (Ob), Grasping (Gr), Visual-Motor Integration (Vi). All of the PDMS-2 subtests contribute to a Total Motor Quotient (TMQ).

  3. Gross Motor Function Measure Scale [ Time Frame: The length of time from birth to the corrected age of 18 months ]
    There is a 4-point scoring system for each item on the GMFM. Specific descriptors for scoring items are detailed in the administration and scoring guidelines. The GMFM-66 requires a user-friendly computer programme called the Gross Motor Ability Estimator, or GMAE, to enter individual item scores and convert them to an interval level total score.

  4. the value of regional homogeneity (ReHo) [ Time Frame: Corrected age of 18 months ]
    a variable from resting-blood oxygenation level dependent（BOLD）sequence of MRI

  5. mean diffusion(MD) [ Time Frame: The length of time from birth to the corrected age of 18 months ]
    a variable from Diffusion Tensor Image（DTI） sequence of MRI


Eligibility Criteria
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Ages Eligible for Study:   3 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Gestational age < 33 weeks;
  2. Correction of gestational age < 3 months;
  3. It has been diagnosed as hypoxic-ischemic encephalopathy, periventricular intraventricular hemorrhage, periventricular leukomalacia, bilirubin encephalopathy, persistent hypoglycemia and cerebral infarction.
  4. There was no other therapeutic intervention before entering the study;
  5. Informed consent is signed by the family.

Exclusion Criteria:

This study is excluded from the study provided that one of the following conditions is met:

  1. Brain injury caused by central or peripheral infection (cerebrospinal fluid positive / torch test positive / three major conventional culture positive);
  2. Brain damage caused by convulsion;
  3. Metabolic brain damage caused by genetic defects;
  4. Suffering from known severe congenital malformations;
  5. Definite head trauma during labor or postpartum;
  6. Peripheral neuromuscular disease or abnormal skeletal system.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527498


Contacts
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Contact: Wenhao Zhou, Prof. +86-21-64931003 zhwchfu@126.com
Contact: Kai Yan, Doc. +86-21-64931168 fhyankai@163.com

Locations
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China, Shanghai
Children Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 201102
Contact: Wenhao Zhou, Doctor    (+86)021-64931003    zwhchfu@126.com   
Sponsors and Collaborators
Children's Hospital of Fudan University
Shanghai 6F+ Early intervention center for high risk preterm infants
More Information
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Publications:

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Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03527498    
Other Study ID Numbers: CHFudanU_NNICU8
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Diseases
Cerebral Infarction
Brain Ischemia
Hypoxia-Ischemia, Brain
Leukomalacia, Periventricular
Kernicterus
Hypoglycemia
Hemorrhage
Infarction
Ischemia
Pathologic Processes
Necrosis
Glucose Metabolism Disorders
Metabolic Diseases
Central Nervous System Diseases
 Nervous System Diseases
Hypoxia
Signs and Symptoms, Respiratory
Brain Infarction
Cerebrovascular Disorders
Stroke
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain
Encephalomalacia
Infant, Premature, Diseases
Infant, Newborn, Diseases
Brain Diseases, Metabolic
Erythroblastosis, Fetal
Hematologic Diseases